EP2468357A1 - Dispositif médical implantable et procédé d'utilisation dans un dispositif médical implantable - Google Patents

Dispositif médical implantable et procédé d'utilisation dans un dispositif médical implantable Download PDF

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Publication number
EP2468357A1
EP2468357A1 EP20100196637 EP10196637A EP2468357A1 EP 2468357 A1 EP2468357 A1 EP 2468357A1 EP 20100196637 EP20100196637 EP 20100196637 EP 10196637 A EP10196637 A EP 10196637A EP 2468357 A1 EP2468357 A1 EP 2468357A1
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EP
European Patent Office
Prior art keywords
immittance
atrial
values
field
dilatation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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EP20100196637
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German (de)
English (en)
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EP2468357B1 (fr
Inventor
Malin Hollmark
Andreas Karlsson
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St Jude Medical AB
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St Jude Medical AB
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Priority to EP10196637.2A priority Critical patent/EP2468357B1/fr
Priority to US13/334,735 priority patent/US20120165692A1/en
Publication of EP2468357A1 publication Critical patent/EP2468357A1/fr
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Publication of EP2468357B1 publication Critical patent/EP2468357B1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6869—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0538—Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/361—Detecting fibrillation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • A61N1/36521—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure the parameter being derived from measurement of an electrical impedance

Definitions

  • the present invention relates to a device and a method according to the preambles of the independent claims, and in particular to a device and a method adapted to determine a risk of atrial fibrillation.
  • Atrial fibrillation is a very common arrhythmia. During episodes of atrial fibrillation, the systolic function of the atria is lost. This results in dilatation of the atria which in turn makes it more difficult for the heart to return to sinus rhythm. Without regular systolic activity the atria will only be passive mediators of blood volume to the ventricles. The degree of dilatation of the atria will reflect the venous return, i.e. preload.
  • RA right atrial
  • AF atrial fibrillation
  • LA left atrial
  • WO-2004/028629 relates to a heart stimulator detecting atrial arrhythmia by determining wall distension by impedance measurement. Upon detection of an atrial arrhythmia the stimulation mode is switched and the pacing rate is adapted to limit the atrial distension.
  • the heart stimulator may also be used for monitoring the degree of atrial distension over an extended period of time to be able to follow the disease development and to enable the physician to adapt therapy accordingly.
  • Atrial fibrillation AF
  • atrial dilatation may be mutually dependent and constitute a vicious circle.
  • LA dilatation has been identified as an independent risk factor for the development of AF.
  • AF results in progressive atrial dilatation, which in turn, might contribute to the self-perpetuating nature of arrhythmia.
  • Atrial dilatation is due to an increase in atrial compliance caused by atrial contractile dysfunction during AF.
  • Atrial size will facilitate the development of atrial fibrillation.
  • an elevated intra-atrial pressure will increase atrial wall stress, which may result in heterogeneities in conduction.
  • atrial dilatation may promote focal arrhythmias that trigger self-perpetuating AF or maintain irregular atrial activation by mechano-electric feedback.
  • the increased inhomogenity in atrial electrophysiological properties during atrial dilatation contributes to the development of AF.
  • interventions targeting a reduction of LA size may prevent AF or AF disease progression.
  • the inventors have identified the relationship between an increased atrial dilatation and the risk of developing atrial fibrillation, and the object of the present invention is to achieve an improved device and method of determining atrial dilatation and, thus, the risk of developing atrial fibrillation.
  • the inventors have found that by using so-called near-field immittance measurements, local measurement values may be determined being specifically suitable for determining a measure of atrial dilatation.
  • the present invention aims at monitoring the heart chamber volumes using impedance. This enables dilatation monitoring and, ultimately, AF or AF disease progression prevention. Early dilatation detection prior to AF can deter the disease progression by early medical intervention.
  • the blood volume in the proximity of an electrode is larger and varies less during the heart cycle than in a normal healthy heart.
  • Such differences between a dilated chamber and a healthy chamber can be detected by measuring and analysing the impedance signal from the chamber in question. Chamber dilatation is detected as a decreased average impedance as well as lower peak-to-peak variation of the impedance.
  • a recorded impedance waveform reflects the superposition of fluid volume around the electrode pair throughout the cardiac and respiratory cycles.
  • RAring electrode right atrial ring electrode
  • SVC superior vena cava
  • impedance measurements associated with the RAring electrode reflects the RA volume. Since RA dilatation follows LA dilatation, monitoring of the RA volume will also provide a monitor of the LA volume.
  • LA left atrial
  • AF atrial fibrillation
  • RA right atrial
  • Impedance measurement of the fluid displacement in the immediate volume surrounding the RAring will provide a measure of dilatation.
  • the present invention also may provide measures to monitor the progression of AF.
  • Implantable medical devices are often equipped to measure impedance (or related electrical parameters such as admittance) between various pairs of electrodes implanted within the patient. Examples include intracardiac impedance measurements made between pairs of electrodes mounted to leads implanted on or within the various chambers of the heart. Other examples include intrathoracic impedance measurements made between the housing of the device (or "can" or "case") and electrodes implanted on or within the heart. Traditionally, such impedance measurements were deemed to be representative of the electrical impedance between the electrodes. That is, impedance measurements were associated with a particular pair of electrodes or some combination of three or more electrodes.
  • these measurements are generally referred to as normal impedance measurements, or only “impedance measurements", because the measurements are associated with at least one pair of electrodes.
  • impedance measurements In terms of analyzing and interpreting the measured impedance data, the interpretation typically relied on a conceptual model wherein the measured impedance was deemed to be representative of the impedance of the field between the electrode pairs, including far-field contributions to that impedance. Under the far-field model, impedance measured between a pair of electrodes A and B is deemed to be representative of the field between A and B.
  • intrathoracic impedance measurements made between the device housing and a cardiac electrode implanted within the heart are deemed to represent the impedance to electrical flow spanning a field extending through the lungs between the device and the cardiac electrode.
  • This intrathoracic impedance measurement may then be used to, for example, assess pulmonary fluid congestion to detect pulmonary oedema (PE) or heart failure (HF).
  • PE pulmonary oedema
  • HF heart failure
  • the present invention is generally directed to the near-field impedance model and various systems, methods and applications that exploit this model.
  • an implantable medical device such as a pacemaker, an implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) device, and a method for use in an implantable medical device, are provided for determining and exploiting near-field immittance values (wherein “immittance” broadly refers to impedance, conductance, admittance or other generally equivalent electrical values or parameters) associated with individual electrodes in accordance with a near-field model that associates immittance values with individual electrodes rather than with pairs of electrodes.
  • immittance broadly refers to impedance, conductance, admittance or other generally equivalent electrical values or parameters
  • the near-field model is based on the recognition that the immittance between a pair of electrodes (A and B) can be modelled as a superposition of near-field immittance values that are associated with the individual electrodes (i.e. A+B). That is:
  • the near-field model transforms multiple pair-based immittance measurement values into a set of near-field immittance values that can be interpreted and analyzed more easily.
  • the conversion of normal impedance measurement values into near-field impedance values is performed by converting N (where N is at least three) impedance measurement values (v1, v2, ... , vN) into a set of linear equations to be solved whereby far-field contributions to impedance are ignored.
  • the set of linear equations are then solved to yield a set of near-field impedance values (e1, e2, ..., eN) associated with the individual electrodes.
  • N+1 impedance measurements are used to determine the near-field impedance values of the N electrodes.
  • the device can easily associate a specific physical entity - such as the particular anatomical structure adjacent to the electrode - with the corresponding near-field immittance value.
  • the corresponding near-field immittance is associated with the local fluid and tissue content within the adjacent RA cavity and RA tissues.
  • each current node reflects the tissue-to-blood proportionality in its immediate surrounding.
  • the following configuration (with reference to figure 2 ) may be used:
  • the three impedance waveforms measured with the three impedance fields are in fact composites made up of the three distinct waveforms from each of the three nodes, A, B and C.
  • the three distinct waveforms are extracted by using the equation system 2 above.
  • the quadrupolar configuration: I: RAring-LVring, U: RAtip-LVtip could replace the bipolar configuration I: RAring-LVring, U: RAring-LVring (where I denotes the current injection nodes and Uthe voltage nodes).
  • impedance impedance
  • the measurements may be performed by using geometries with four poles (e.g. RAring/RAtip, LAring(s)/LAtip, RVring/RVtip and Case). This would provide mean impedance values for the electrodes in the measured configurations.
  • the triangle could then e.g. include the following configurations: RAring-Case, RAring-RVcoil, RVcoil-Case; where the RAring-electrode is of particular interest.
  • FIG 1 is schematically shown an implantable medical device according to the invention.
  • the implantable medical device is connectable to at least three electrodes.
  • the electrodes, to which the implantable medical device is connectable may, for example, be selected from the group of: the case (or can) of the implantable medical device, RAring electrodes, an RAtip electrode, LAring electrodes, an LAtip electrode, LVring electrodes, an LVtip electrode, RVring electrodes, an RVtip electrode, RVcoil electrodes or SVCoil electrodes.
  • the input signals from the electrodes are indicated by three parallel arrows.
  • the implantable medical device comprises an immittance measurer operative to perform immittance measurements within the heart of a patient using at least three of said electrodes where at least one of the electrodes is arranged in an atrium of the patient's heart.
  • FIGS 4 and 5 illustrate two different electrode set-ups which both would be applicable in relation to the present invention.
  • the medical device further comprises an immittance converter operative to convert immittance measurement values into individual near-field immittance values of at least one of the at least one electrode being arranged in an atrium.
  • the device in addition comprises an atrial dilatation detector operative to detect atrial dilatation based upon the individual near-field immittance values, and to determine atrial dilatation values in dependence thereto.
  • An atrial fibrillation risk determiner is also included in the device, which risk determiner is adapted to determine an atrial fibrillation risk index based upon the atrial dilatation values.
  • the atrial fibrillation risk determiner is adapted to generate an atrial fibrillation risk signal in dependence of the risk index.
  • the atrial dilatation detector may also comprise a memory unit for storage of the determined atrial dilatation values.
  • the atrial fibrillation risk determiner may comprise a comparison unit provided with at least one atrial fibrillation risk threshold.
  • the comparison unit is adapted to compare the determined atrial dilatation values with the at least one fibrillation risk threshold and the atrial fibrillation risk determiner is adapted to determine the atrial fibrillation risk index in dependence of the comparison.
  • the atrial fibrillation risk threshold is an atrial dilatation value for which the risk of atrial fibrillation is considered to be significant.
  • the upper curve shows the impedance from a healthy heart chamber and the lower curve shows the impedance from a dilated heart chamber, e.g. from a right atrial ring electrode.
  • a dilated heart chamber e.g. from a right atrial ring electrode.
  • the DC-level is the average of the measured impedance.
  • Another difference is the AC-amplitude, which is smaller for the dilated chamber than for the healthy heart chamber. This is caused by the inelasticity of the heart wall during AF.
  • the AC-amplitude is the peak-to-peak variation of the impedance.
  • the determined atrial fibrillation risk index is based upon the variations of the determined atrial dilatation values during a preset time period.
  • the atrial dilatation variation during healthy periods can also be considered when setting the thresholds for what is to be considered a pathological change of the atrial dilatation.
  • the risk index may be based upon the variations of the determined atrial dilatiation values.
  • a measurement session during which the immittance measurements are performed, has preferably a duration of some seconds, at least one respiration cycle or a number of heart cycles, and is performed at regular intervals, e.g. once every hour or every two hours.
  • the graphs illustrated in figures 7 and 8 show impedance values during three days and may be regarded to show short-term changes. Long-term changes may be identified during time periods of weeks, months or even years.
  • one atrial electrode is an RAring electrode.
  • Figures 4 and 5 show an RAring electrode arranged in the right atrium. The immittance measurement of the fluid volume surrounding the RAring will provide a measure of dilatation of the right atrium.
  • one atrial electrode is an LAring electrode and the immittance measurement of the fluid volume surrounding the LAring will provide a measure of dilatation of the left atrium. This is also illustrated in figure 4 .
  • One specific embodiment of the present invention is achieved when the immittance measurements are made between electrodes that correspond to an impedance triangle, i.e. when the immittance measurements are performed with measurement nodes arranged in a triangle.
  • the immittance converter is adapted to convert the immittance measurement values into relative near-field immittance values by ignoring far-field contributions. More specifically, the immittance converter is adapted to convert the immittance measurement values into near-field immittance values by converting at least N immittance measurement values (v1, v2, ..., vN) into a set of linear equations to be solved while ignoring the far-field contributions to the immittance measurements, where N is at least three, and by solving the set of linear equations to yield a set of near-field immittance values (e1, e2, ..., eN).
  • the present invention also relates to a method for use in an implantable medical device for implantation within a patient.
  • the method comprises:
  • the method includes generating an AF risk signal in dependence of said risk index.
  • the method may further include comparing the determined atrial dilatation values with at least one atrial fibrillation risk threshold and generating the atrial fibrillation risk index in dependence of the comparison.
  • the determined atrial fibrillation risk index is based upon the variations of the determined atrial dilatation values during a preset time period, which is discussed in detail above.
  • one of the at least one atrial electrode is an RAring electrode and the immittance measurement of the fluid volume surrounding the RAring will provide a measure of atrial dilatation.
  • one of the at least one atrial electrode is an LAring electrode and the immittance measurement of the fluid volume surrounding the LAring will provide a measure of atrial dilatation.
  • One specific embodiment of the present invention is achieved when the immittance measurements are made between electrodes that correspond to an impedance triangle, i.e. when the immittance measurements are performed with measurement nodes arranged in a triangle.
  • the conversion of the immittance measurement values into relative near-field immittance values is achieved by ignoring far-field contributions to the impedance measurements, which specifically is achieved by:
  • the method preferably includes the step of controlling at least one device function in response to the near-field immittance values.
  • This may be a specifically tailored stimulation mode adapted to reduce the effect of AF, or even to prevent the occurrence of AF.
  • FIGS. 4 and 5 illustrate two different electrode set-ups which both would be applicable in relation to the present invention.
  • a lead located in the left atrium, as well as in the right, would provide near-field impedance from that specific location and the near-field impedance signals from both atria can be monitored. This would indicate where the dilatation and therefore the fibrotic tissue reside.
  • the fibrosis of tissue is a consequence of the atrial remodelling, which, in turn, is caused by the activation of hormone systems as a response to the atrial dilatation.
  • the fibrotic tissue might be the substrate for AF and subsequently the origin of AF.
  • a dilatation originating in the RA may be indicative of a right-sided disease, such as pulmonic or tricuspid valve stenosis, pulmonary disease or chronic obstructive pulmonary disease (COPD).
  • a dilatation originating in the LA may be indicative of e.g. aortic or mitralis valve stenosis or systemic hypertension. The invention could thus provide an improved monitoring of disease progression and dilatation/AF.
  • Figure 6 shows a graph illustrating impedance signals from a healthy heart chamber (upper curve) that will have a higher DC level and larger peak-to-peak amplitude than a signal originating from a dilated chamber (lower curve).
  • Figure 7 shows impedance signals from a pre-clinical study.
  • the upper lines are the recorded signals from three Z configurations in an impedance triangle 1.
  • the impedance triangle is formed between left ventricle ring electrode (LVr) which could be one of LVring1, LVring2 or LVring3 in figure 4 , right atrial ring electrode (RAr) which is denoted RAring in figure 4 , and the case.
  • the three lower lines are the near-field signals for the respective electrode extracted through the equation system outlined above.
  • the relationship between different anatomical regions in the heart may be reflected by the signals obtained from one or several impedance triangles. For instance, by comparing the different terms (electrode nodes) in one impedance triangle, or the relation between electrode nodes from several impedance triangles, e.g. the configuration RAring-LVring included in the impedance triangle referred to in relation to figure 7 , and another impedance triangle formed e.g. by the electrodes RAring, LVring3 and the case (can) by references to figures 4 or 5 .
  • the two different RAring signals will be extracted from two equation systems formed by the two impedance triangles and these signals will reflect the near-field in the RA produced by two different configurations.

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EP10196637.2A 2010-12-22 2010-12-22 Dispositif médical implantable Not-in-force EP2468357B1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP10196637.2A EP2468357B1 (fr) 2010-12-22 2010-12-22 Dispositif médical implantable
US13/334,735 US20120165692A1 (en) 2010-12-22 2011-12-22 Implantable medical device and a method for use in an implantable medical device

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Application Number Priority Date Filing Date Title
EP10196637.2A EP2468357B1 (fr) 2010-12-22 2010-12-22 Dispositif médical implantable

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EP2468357A1 true EP2468357A1 (fr) 2012-06-27
EP2468357B1 EP2468357B1 (fr) 2015-10-28

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Families Citing this family (7)

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Publication number Priority date Publication date Assignee Title
US8812093B2 (en) * 2010-08-09 2014-08-19 Pacesetter, Inc. Systems and methods for exploiting near-field impedance and admittance for use with implantable medical devices
US8670820B2 (en) * 2010-08-09 2014-03-11 Pacesetter, Inc. Near field-based systems and methods for assessing impedance and admittance for use with an implantable medical device
US10874860B2 (en) 2016-07-20 2020-12-29 Cardiac Pacemakers, Inc. Method and system for determining a cardiac cycle pace time in accordance with metabolic demand in a leadless cardiac pacemaker system
US11147965B2 (en) 2016-07-20 2021-10-19 Cardiac Pacemakers, Inc. Method and system for determining pace timing in a leadless cardiac pacemaker system
US10918858B2 (en) 2016-07-20 2021-02-16 Cardiac Pacemakers, Inc. Cardiac volume sensing via an implantable medical device in support of cardiac resynchronization therapy
JP7038115B2 (ja) 2016-10-27 2022-03-17 カーディアック ペースメイカーズ， インコーポレイテッド 圧力センサを備えた植込み型医療装置
EP3668592B1 (fr) 2017-08-18 2021-11-17 Cardiac Pacemakers, Inc. Dispositif médical implantable avec capteur de pression

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EP1384433A1 (fr) * 2002-07-22 2004-01-28 St. Jude Medical AB Appareil de detection anticipée de maladies cardiaques ischémiques
WO2004008959A1 (fr) * 2002-07-22 2004-01-29 St Jude Medical Ab Moniteur d'insuffisance cardiaque congestive
WO2004028629A1 (fr) 2002-09-30 2004-04-08 St. Jude Medical Ab Stimulateur cardiaque detectant l'arythmie atriale par determination de la distension de la paroi par mesure d'impedance
WO2009096820A1 (fr) * 2008-01-28 2009-08-06 St.Jude Medical Ab Dispositif médical pour pronostiquer une fibrillation atriale

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US8670820B2 (en) * 2010-08-09 2014-03-11 Pacesetter, Inc. Near field-based systems and methods for assessing impedance and admittance for use with an implantable medical device

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Publication number Priority date Publication date Assignee Title
EP1384433A1 (fr) * 2002-07-22 2004-01-28 St. Jude Medical AB Appareil de detection anticipée de maladies cardiaques ischémiques
WO2004008959A1 (fr) * 2002-07-22 2004-01-29 St Jude Medical Ab Moniteur d'insuffisance cardiaque congestive
WO2004028629A1 (fr) 2002-09-30 2004-04-08 St. Jude Medical Ab Stimulateur cardiaque detectant l'arythmie atriale par determination de la distension de la paroi par mesure d'impedance
WO2009096820A1 (fr) * 2008-01-28 2009-08-06 St.Jude Medical Ab Dispositif médical pour pronostiquer une fibrillation atriale

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Title
J ZHAO ET AL.: "Effects of spironolactone on atrial structural remodelling in a canine model of atrial fibrillation produced by prolonged atrial pacing", BRITISH JOURNAL OF PHARMACOLOGY, vol. 159, 2010, pages 1584 - 1594
RAVELLI, MECHANO-ELECTRIC FEEDBACK AND CARDIAC ARRHYTHMIAS, PROGRESS IN BIOPHYSICS AND MOLECULAR BIOLOGY, vol. 82, no. 1-3, 2003, pages 137 - 149

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